BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Olerup SSP® HLA typing kits

    Reg #: 3002522915 · FEI: 3002522915 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CAREDX AB
    Registration Number
    3002522915
    FEI Number
    3002522915
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Franzengatan 5
    City
    STOCKHOLM
    Country
    SE

    Regulatory Submissions

    510(k) Number
    BK080022

    Owner / Operator

    Firm Name
    CareDx AB
    Operator Number
    10029422
    Address
    Franzengatan 5
    City
    Stockholm
    State
    SE-AB
    Postal Code
    11251
    Country
    SE
    Correspondent
    Maria Ilar

    US Agent

    Business Name
    CareDx Inc.
    Contact Name
    Wilk von Gustedt
    Address
    3260 Bayshore Boulevard
    City
    Brisbane
    State
    CA
    ZIP
    94005
    Country
    US
    Email
    [email protected]
    Phone
    415 2872312

    Products

    Device Name Product Code
    Test, Qualitative, For Hla, Non-Diagnostic MZI

    Proprietary Names

    Olerup SSP® HLA typing kits

    Establishment Types

    Manufacture Medical Device